FDA 510(k) Application Details - K970771

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K970771
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	RESMED LTD. 82 WATERLOO RD. NORTH RYDE SYDNEY, NEW SOUTH WALES 2113 AU Other 510(k) Applications for this Company
Contact	MICHAEL HALLETT Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/1997
Decision Date	06/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review